This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: The rapidly dissolving tablets may contain aspartame or phenylalanine. If you have phenylketonuria PKU or any other condition that requires you to restrict your intake of aspartame or phenylalanine, consult your doctor or pharmacist regarding the safe use of this medicine.
Antibiotics may rarely cause a severe intestinal condition Clostridium difficile -associated diarrhea due to a type of resistant bacteria. This condition may occur weeks after antibiotic treatment has stopped.
This medication may make this condition worse. For pediatric patients 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Total daily dosage should not exceed recommended dosages for the first day. Chronic Diarrhea Adults The recommended initial dose is 4 mg two capsules followed by 2 mg one capsule after each unformed stool until diarrhea is controlled, after which the dosage of Loperamide hydrochloride capsules should be reduced to meet individual requirements.
When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses. The average daily maintenance dosage in clinical trials was 4 mg to 8 mg two to four capsules per day. The maximum daily dosage is 16 mg eight capsules per day. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration.
Loperamide hydrochloride capsules administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment. Elderly No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients.
No dose adjustment is required for the elderly. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval. Renal Impairment No pharmacokinetic data are available in patients with renal impairment. Hepatic Impairment The pharmacokinetics of Loperamide have not been studied in patients with hepatic impairment. In many cases of loperamide overdosage, anti-arrhythmic medications e. Electrical cardioversion and overdrive pacing, and isoproterenol continuous infusion were reported to manage QTc prolongation in the setting of overdose.
Laboratory Testing Loperamide serum concentrations are not widely available or clinically useful to guide patient management. CNS and Respiratory Depression Symptoms Cases of loperamide overdose including relative overdose due to hepatic dysfunction , may cause opioid toxic effects including CNS depression e.
Pediatric patients may be more sensitive to CNS effects, including respiratory depression, than adults. Management Loperamide non-cardiac arrhythmia overdosages should be treated as opioid overdosages.
Naloxone may reverse the opioid-related toxicity, including CNS and respiratory depression, and hypotension, associated with loperamide overdosage. In adults and pediatric patients, naloxone may be administered intravenously. Appropriate doses of naloxone, via intranasal, intramuscular, intraosseus, or subcutaneous administration may be necessary if the intravenous route is not available.
If the desired degree of opioid-related toxicity counteraction and improvement are not obtained, naloxone may be repeated at two- to three-minute intervals.
If no response in opioid-related effects is observed after naloxone has been administered, then diagnosis of opioid-induced toxicity should be questioned. Refer to the naloxone prescribing information for complete information on initial and subsequent dosages. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate or when indicated. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.
Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM loperamide hcl should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity.
No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of loperamide in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.
Fertility and reproductive performance was evaluated in rats using oral doses of 2. Pregnancy Teratogenic Effects Pregnancy Category C Teratology studies have been performed in rats using oral doses of 2. The studies produced no evidence of teratogenic activity.
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